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CTRI Number  CTRI/2026/01/101060 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Temperature monitoring with zero heat-flux technology (3M SpotOn) in comparison with nasopharyngeal temperature during long surgeries - An observational study. 
Scientific Title of Study   Intra-operative non-invasive temperature monitoring with zero heat-flux technology (3M SpotOn) in comparison with nasopharyngeal temperature - An observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasanna Kini 
Designation  Secondary DNB Student 
Affiliation  Fortis Hospital  
Address  Department of Anaesthesiology, Fortis Hospital, Mulund Goregaon Link Road, Bhandup West, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400078
India 
Phone  9819489493  
Fax    
Email  prasannakini@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amruta Kulkarni 
Designation  Consultant 
Affiliation  Fortis Hospital 
Address  Department of Anaesthesiology, Fortis Hospital, Mulund Goregaon Link Road, Bhandup West, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400078
India 
Phone  9820789650  
Fax    
Email  amrutaajgaonkar9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amruta Kulkarni 
Designation  Consultant 
Affiliation  Fortis Hospital 
Address  Department of Anaesthesiology, Fortis Hospital, Mulund Goregaon Link Road, Bhandup West, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400078
India 
Phone  9820789650  
Fax    
Email  amrutaajgaonkar9@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Fortis Hospital 
Address  Mulund Goregaon Link Road, Bhandup West, Mumbai - 400078 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanna Kini  Fortis Hospital, Mulund  Mulund Goregaon Link Road, Bhandup West, Mumbai -400078
Mumbai (Suburban)
MAHARASHTRA 		 9819489493

prasannakini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA Physical Status 1-3 
 
ExclusionCriteria 
Details  Patient refusal
Patients for oral or nasal surgeries.
Patients undergoing upper oesophageal surgeries.
Unavailability of Forehead site to attach SpotOn Thermometer. (BIS, NIRS monitored patients)
Patients with skin lesions/disease over face or forehead.
Patients for neurosurgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the accuracy of the SpotOn Zero Heat-flux thermometer for its ability to measure core temperature within 0.5 degrees Celsius of the nasopharyngeal probe-based temperature measurement.  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the trend of core temperature monitoring by the two mentioned techniques.
2.To compare the initial core temperature readings using the two mentioned technologies.
3.To compare the trend of change in readings along with time and hemodynamic changes during the surgery.
 		 9 months 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prasannakini@gmail.com].

  6. For how long will this data be available start date provided 07-09-2026 and end date provided 07-06-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a prospective, observational study which will be aimed to be completed in 9 months from the date of approval of the ethics committee. It will include subjects from the age of 18 to 70 years. The primary outcome will be to compare the two temperature measurement technologies for core body temperature.  
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